BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    Profoject™ Safety Pen Needles

    K Number: K260855 · Decision Jun 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    8
    Review Days
    86

    Basic Information

    Device Name
    Profoject™ Safety Pen Needles
    K Number
    K260855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CMT Health PTE., Ltd.
    Date Received
    March 16, 2026
    Decision Date
    June 10, 2026
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by CMT Health PTE., Ltd.

    K Number Device Name
    K260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle
    K253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
    K253068 Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe
    K252814 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe
    K252631 Profoject™ Disposable Needle
    K252033 Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
    K251585 Profoject™ Enteral Feeding Syringe